Case study

16 Dec 2020

Double-Blind Global Study (USA +/India/ Europe in Cancer patients)


Overview

This double-blind study required adult patients undergoing moderately to highly emetogenic chemotherapy regimes to establish the efficacy and safety of a single-dose, sustained release formulation of the test article for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). This was one of the largest CINV trials to date. TFS was selected to provide full CRO services including site identification/initiation/training; patient enrollment; project management/monitoring; data management; biostatistics & programming; medical writing, and regulatory consulting.


    Challenges

    • Patient enrollment—competition with oncology treatment trials
    • Global Trial – USA, India, Europe
    • Restrictive inclusion/exclusion criteria
    • Complex study design — observer-blind; unique drug delivery system; standardized dosing requirements
    • Investigator site staff turnover throughout multi-year study duration
    • Embedded PK/Holter monitoring sub-study

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